Leishmaniasis

Researchers are studying how eosinophils, a type of white blood cell, become activated and their role in immune reactions. Eosinophils often increase with allergies, asthma, parasitic infections, some autoimmune diseases, and rarely tumors, a condition called eosinophilia. While usually without symptoms, eosinophilia can sometimes cause swelling, itching, lung problems, heart disease, or nerve damage due to toxic substances released by these cells. Participants with eosinophil counts above 750/ml or abnormal eosinophil buildup in tissues or skin will have thorough medical exams, blood tests, and possibly additional tests based on age and symptoms. This observational study does not offer experimental treatments but monitors clinical responses and collects blood, bone marrow, tissue, and fluid samples for research. Follow-up includes yearly evaluations and may involve bone marrow biopsies, genetic testing, and leukapheresis for adults. Participants will be involved in detailed clinical evaluations at baseline and annually, with sample collections to study disease mechanisms and immune responses. The study aims to identify causes, biomarkers, and treatment effects on eosinophils. Safety monitoring includes standard care for those needing treatment, while research focuses on immune cell behavior, genetic factors, and long-term effects. Participation duration varies per individual, with ongoing assessments of disease activity and patient-reported outcomes.

Researchers are evaluating the safety and effectiveness of arnica tincture as a topical treatment for localized cutaneous leishmaniasis (CL), a parasitic skin disease caused by Leishmania species. The study compares arnica tincture to the current local treatment with intralesional pentavalent antimonials. This trial builds on prior research showing positive results for arnica tincture in Colombia and aims to offer a potentially safer option with fewer systemic side effects. This is a randomized, single-blind clinical trial including two treatment groups. One group will apply arnica tincture topically three times a day for 30 days, while the other will receive intralesional injections of pentavalent antimonials once weekly for five weeks, dosed by lesion size. Both treatments target localized skin lesions caused by CL, and the study evaluates the safety and healing outcomes of these approaches. Participants will be assessed through clinical examinations of their lesions at regular intervals up to 90 days post-treatment to measure healing rates. Safety will be monitored by recording adverse effects. Follow-up visits will continue for more than three months to observe final healing status and any treatment-related issues. The trial aims to provide data on both effectiveness and side effects to inform future treatment choices for CL patients.

Researchers are evaluating the effectiveness of intralesional ciprofloxacin 0.2% solution compared to intralesional sodium stibogluconate (SSG) 10% intravenous solution for treating cutaneous leishmaniasis. This phase 2 randomized parallel groups clinical trial aims to compare these two local injection therapies for patients with cutaneous leishmaniasis lesions. Participants are divided into two groups receiving either weekly intralesional injections of ciprofloxacin at a dose of 2 mg/cm2 or sodium stibogluconate at 1 mg/cm2. Both treatments are given once weekly for up to six weeks. Each lesion is injected using a fine insulin needle until the base is blanched, with volumes ranging from 0.2 to 4.0 ml per lesion depending on size. Treatment stops early if lesions are cured before six weeks. During the study, each lesion is followed for up to 90 days or until it is cured. Patients attend weekly visits for injections and lesion assessments. Researchers measure the cure rate from enrollment to the end of treatment within the 90-day follow-up. Safety and response are closely monitored throughout the study period.

Researchers are conducting a prospective cohort study to develop a tool that predicts relapse in patients with visceral leishmaniasis (VL) from endemic regions in Ethiopia. The study aims to identify factors that influence prognosis by thoroughly assessing clinical and laboratory data before and during treatment. This effort seeks to improve patient care, reduce death and illness rates, and enhance monitoring for those at risk of VL relapse. The study involves comprehensive clinical and laboratory evaluations of confirmed VL patients. These assessments include a wide range of parameters such as immune markers, blood tests including coagulation profiles and cultures, and clinical conditions like sepsis and comorbidities. The goal is to create prognostic tools of varying complexities suited to different healthcare settings, which will help stratify patients into high and low risk groups for relapse, treatment failure, and mortality. Participants will undergo detailed follow-up throughout treatment to collect data that helps identify risk factors for relapse, treatment failure, and death. The main outcomes measured include the development of the prognostic tool and identification of key risk factors by December 2026. This observational study monitors patients without any intervention, focusing on improving understanding and management of VL through ongoing clinical and laboratory evaluations.

Researchers are studying the natural history and treatment of leishmanial infections in patients aged 3 to 100 years. The study aims to better understand leishmaniasis, improve diagnostic tests, and observe how different species and host factors affect disease resistance and relapse. The National Institute of Allergy and Infectious Diseases (NIAID) is leading this observational research. Patients suspected or known to have leishmaniasis will undergo routine blood tests and biopsies tailored to the infection type: cutaneous, mucocutaneous, or visceral. Treatment varies by infection type and may include medications like Pentostam, amphotericin B, itraconazole, or ketoconazole with different dosing schedules and administration methods such as infusions or oral pills. Some patients may have skin tests similar to tuberculin testing, and treatments involve monitoring through blood draws, electrocardiograms, and urinalysis. Participants may have photographs taken and provide extra blood samples for research. Follow-up visits depend on the infection type, ranging from short-term (2 weeks to 3 months) for cutaneous cases to indefinite routine evaluations every 3 to 6 months for mucocutaneous and visceral infections. Researchers will assess clinical and immune responses, treatment safety and effectiveness, and collect genetic and immune data over time to understand infection outcomes.

Researchers are evaluating the safety, tolerability, and effectiveness of adding metformin to standard multidrug therapy (MDT) for patients newly diagnosed with multibacillary leprosy. This double-blind, placebo-controlled Phase 2 trial aims to see if metformin can reduce leprosy reactions, nerve damage, and corticosteroid use while assessing immunological responses. The study is supported by the Leprosy Research Initiative and conducted in Indonesia with participants aged 18 to 65. Participants will be randomly assigned to receive either metformin or a placebo once daily. Metformin dosing starts at 500mg for two weeks, then increases to 1000mg for 22 weeks, alongside 48 weeks of standard MDT. The placebo group receives matching tablets to maintain blinding. The trial plans to enroll 166 patients to compare clinical outcomes between the two groups. During the 48-week study, participants will be regularly monitored for leprosy reactions, adverse events, nerve function, corticosteroid use, and quality of life through clinical assessments and questionnaires. The primary outcomes include the proportion of patients experiencing leprosy reactions and adverse events within specified timeframes. Secondary outcomes focus on reaction severity, timing, frequency, and impact on daily living. Safety and tolerability will also be closely observed throughout the study period.

Researchers are evaluating the protective efficacy of Mossie-GO, an active spatial repellent device that releases transfluthrin, to reduce malaria prevalence in children 5 years old and younger in Uganda. This cluster-randomized, double-blinded control trial aims to measure how well the device lowers malaria cases confirmed by rapid diagnostic tests and microscopy, while also assessing its impact on mosquito behavior, resistance, and diversion effects on nearby unprotected individuals. The study includes surveys and safety monitoring. The Mossie-GO device is a small solar-powered fan unit that holds repellent discs treated with transfluthrin, designed to prevent mosquito bites and reduce mosquito populations when used overnight for 8 to 12 hours. Households in the intervention group receive devices with treated discs and monthly refills, while control households receive devices with untreated blank discs and refills to maintain blinding. The device is placed in the room where the enrolled child sleeps. Participants continue standard malaria prevention such as bed nets. Participants are monitored at baseline and followed for up to 18 months, covering two malaria transmission seasons. Assessments include malaria testing in children using blood tests, household surveys, mosquito collection with light traps and human landing catches, air sampling to measure repellent concentration, and acceptability surveys. Data on adverse events and intervention safety are collected. The trial involves 56 clusters with about 100 households sampled for detailed evaluation in core zones, plus additional monitoring in buffer zones.

Researchers are investigating vector-borne diseases, which are infections caused by bites from mosquitoes, flies, fleas, ticks, or other blood-feeding insects. These diseases contribute to nearly one million deaths annually and are increasing, especially in Southeast Asia. This study aims to better understand these illnesses in Cambodia, where they may account for about 10% of fevers, by identifying pathogens using advanced metagenomic sequencing techniques. Participants include people aged 2 months to 65 years who have a fever of at least 38 degrees Celsius or have been diagnosed with important infectious pathogens. Close contacts of infected individuals may also join. Participants provide information about their health, travel, sex, age, and residence. Blood samples are collected, and nasal swabs are taken if respiratory symptoms are present. Optional follow-up blood samples and nasal swabs may be taken within 1-2 weeks and/or up to 3 months after enrollment. During the study, participants complete questionnaires and undergo medical history screening. Children are weighed to ensure suitability for blood sampling. The researchers will analyze pathogen sequences from samples collected between day 0 and 2 of enrollment and assess immune reactions to insect saliva. This study includes long-term tracking through optional follow-up samples to better understand disease spread and impact in the region.

Researchers are studying patients with filarial infections, which are caused by parasitic worms transmitted by mosquito bites. These infections can range from no symptoms to serious issues like swelling, allergic lung problems, skin rashes, eye inflammation leading to blindness, and heart disease. The study aims to explore the immune response to these infections, including how susceptible people are, how the disease develops, and how patients respond to treatment. Participants diagnosed with or suspected of having filarial infections will undergo standard medical tests to identify the specific parasite type. Depending on the infection, tests may include lung, skin, or heart examinations, and some may have a skin biopsy or bronchoalveolar lavage if medically necessary. Treatment will follow standard care using diethylcarbamazine or ivermectin based on the infection type. Additional research procedures include extra blood draws, urine collections, skin allergy tests, and leukapheresis for immune cell collection in adults. During the study, participants will have more frequent follow-up visits than usual, including physical exams and blood tests. Researchers will collect blood and serum samples to study immune responses and monitor how patients clinically and immunologically respond to treatment over time. The main outcome is to understand the factors affecting infection susceptibility, disease progression, and treatment response, with long-term observation planned for up to 10 years.

Researchers are studying Leishmaniasis, a parasitic infection, to identify specific biomarkers that could improve blood tests for detecting the disease. The study aims to find biomarkers that do not cross-react with other infections such as Chagas, tuberculosis, leprosy, or malaria. It also examines the Antigen Recognition Patterns (ARPs) of Leishmania infection and whether these patterns apply to different strains from Italy, Sudan, and other regions. The study involves analyzing stored and newly collected blood and serum samples from patients with confirmed Leishmaniasis, uninfected individuals, and those with other infections. Researchers use a specialized diagnostic test called Western blot to examine different protein fractions from Leishmania strains. They identify specific immunogenic proteins through laboratory techniques including mass spectrometry. Participants contribute blood samples that are tested and analyzed for biomarkers and ARPs. The study reviews these patterns at baseline to understand cross-reactions with other diseases. Samples come from multiple groups, including Leishmaniasis patients, healthy controls, and individuals with other infections. The research is observational with no assigned treatments, and participation involves providing samples and medical data. The study is expected to continue until November 2026.